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Efficacy of Hypnoanalgesia by a Radiologist Technologist in Children With Cutaneous Angioma Treated With Sclerosis in Interventional Radiology (HYP-ANGE)

Primary Purpose

Angioma

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Hypnoanalgesia group
Meopa Group
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Angioma focused on measuring hypnoanalgesia, cutaneous angioma, sclerosis treatment

Eligibility Criteria

7 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Child requiring a first treatment with sclerosis cutaneous angioma whose location allows treatment in interventional radiology room,
  • Child from 7 to 18 years old on the day of treatment,
  • Free and informed consent of the child and his parents (or legal representative),
  • Patient affiliated to a social security scheme

Exclusion Criteria:

  • Child under tutorship or guardianship,
  • Child suffering from severe psychotic disorders or under psychotropic drug treatment,
  • Child who has already had angioma sclerosis in the interventional radiology room. Indeed, the child can remember a previous support and have a priori, positive or negative, on the new support (memory bias),
  • Child not speaking French,
  • Deaf child or hearing impaired not allowing easy listening

Sites / Locations

  • Hôpital Femme Mère Enfant

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Hypnoanalgesia group

MEOPA Group

Arm Description

It is performed by a radiologist technologist who has been trained in Ericksonian hypnoanalgesia in the Hospices Civils de Lyon and has been practicing it regularly for 1 year.

The pain management will be done exclusively by a mask delivering the equimolecular mixture of oxygen and nitrous oxide (MEOPA)

Outcomes

Primary Outcome Measures

assessment of pain score by Visual Analog Scale (EVA)
Comparison of the pain score felt by the child during the procedure (score 0 or 1, absence or presence of pain, on an Analog Visual Scale (EVA)) between the MEOPA group and the hypnoanalgesia group.

Secondary Outcome Measures

Patient anxiety score assessed by anxiety Visual Analog Scale (EVA)
number of side effects
comparaison between groups.
gravity of side effects
comparaison between groups.
Patient satisfaction assessed by a satisfaction questionary
Pain assessed by Visual Analog Scale (EVA)
anxiety assessed by Visual Analog Scale (EVA)
number of injections performed per site
MEOPA administration time

Full Information

First Posted
September 14, 2018
Last Updated
October 18, 2023
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT03674346
Brief Title
Efficacy of Hypnoanalgesia by a Radiologist Technologist in Children With Cutaneous Angioma Treated With Sclerosis in Interventional Radiology
Acronym
HYP-ANGE
Official Title
Efficacy of Hypnoanalgesia by a Radiological Radiologist Technologist in Children With Cutaneous Angioma Treated With Sclerosis in Interventional Radiology
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2024 (Anticipated)
Primary Completion Date
January 2026 (Anticipated)
Study Completion Date
January 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study highlights the global management of the various components of outpatient pain by hypnoanalgesia (pain management by hypnosis) in radiopediatrics. Indeed, pain is induced by sclerosis of cutaneous angiomas in interventional radiology. It is managed by MEOPA (an equimolar mixture of oxygen nitrous oxide) or by general anesthesia. For four years, the medical electroradiology technologist of the Mother and Child Hospital (HFME) of the Hospices Civils de Lyon offer patients in addition a pain management by hypnoanalgesia. The investigator propose a multicenter open randomized study comparing two pain management strategies, in children aged 7 to 18 years treated for cutaneous angioma by sclerosis in interventional radiology at the HFME. The two strategies studied are: Hypnoanalgesia and MEOPA (the reference strategy). The main objective is to evaluate the efficacy of hypnoanalgesia compared to the standard of care of pain, which is the use of MEOPA, in the treatment of sclerosis of cutaneous angioma in pediatric interventional radiology.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Angioma
Keywords
hypnoanalgesia, cutaneous angioma, sclerosis treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
138 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hypnoanalgesia group
Arm Type
Experimental
Arm Description
It is performed by a radiologist technologist who has been trained in Ericksonian hypnoanalgesia in the Hospices Civils de Lyon and has been practicing it regularly for 1 year.
Arm Title
MEOPA Group
Arm Type
Other
Arm Description
The pain management will be done exclusively by a mask delivering the equimolecular mixture of oxygen and nitrous oxide (MEOPA)
Intervention Type
Other
Intervention Name(s)
Hypnoanalgesia group
Intervention Description
The running of a hypnosis session is protocolized and is based on three times: The hypnotic induction time that allows to move from the state of consciousness to a modified state of consciousness: it will be adapted according to the patient as specified by the procedure of Ericksonian hypnosis. It varies from a few seconds to 10 minutes. Induction time depends on the patient's level of stress, apprehension, subsequent experiences of hospitalization, history, and level of hypnotizability. The dissociation time. It is the state of modified consciousness obtained at the end of the induction which is prolonged, The time of "return". It is time that allows the patient to regain his classic state of consciousness.
Intervention Type
Other
Intervention Name(s)
Meopa Group
Intervention Description
The pain management will be done exclusively by a mask delivering the equimolecular mixture of oxygen and nitrous oxide (MEOPA) throughout the procedure. For optimal use, the beginning of its administration by the radiological technologist is performed 3 minutes before the sclerosant injection (at the end of the locating ultrasound). The end of administration will correspond to the end of the injections of the sclerosing product. These sclerosing products are not considered experimental or ancillary products in this study.
Primary Outcome Measure Information:
Title
assessment of pain score by Visual Analog Scale (EVA)
Description
Comparison of the pain score felt by the child during the procedure (score 0 or 1, absence or presence of pain, on an Analog Visual Scale (EVA)) between the MEOPA group and the hypnoanalgesia group.
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
Patient anxiety score assessed by anxiety Visual Analog Scale (EVA)
Time Frame
Day 0
Title
number of side effects
Description
comparaison between groups.
Time Frame
Day 0
Title
gravity of side effects
Description
comparaison between groups.
Time Frame
Day 0
Title
Patient satisfaction assessed by a satisfaction questionary
Time Frame
Day 0
Title
Pain assessed by Visual Analog Scale (EVA)
Time Frame
Day 0
Title
anxiety assessed by Visual Analog Scale (EVA)
Time Frame
Day 0
Title
number of injections performed per site
Time Frame
Day 0
Title
MEOPA administration time
Time Frame
Day 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Child requiring a first treatment with sclerosis cutaneous angioma whose location allows treatment in interventional radiology room, Child from 7 to 18 years old on the day of treatment, Free and informed consent of the child and his parents (or legal representative), Patient affiliated to a social security scheme Exclusion Criteria: Child under tutorship or guardianship, Child suffering from severe psychotic disorders or under psychotropic drug treatment, Child who has already had angioma sclerosis in the interventional radiology room. Indeed, the child can remember a previous support and have a priori, positive or negative, on the new support (memory bias), Child not speaking French, Deaf child or hearing impaired not allowing easy listening
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Claire BENOIT-RUBY
Phone
474855098
Ext
+33
Email
claire.benoit-ruby@chu-lyon.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Adeline Mansuy
Phone
472115170
Ext
+33
Email
adeline.mansuy@chu-lyon.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claire BENOIT-RUBY
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Femme Mère Enfant
City
Bron
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claire BENOIT-RUBY
Email
claire.benoit-ruby@chu-lyon.fr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Efficacy of Hypnoanalgesia by a Radiologist Technologist in Children With Cutaneous Angioma Treated With Sclerosis in Interventional Radiology

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